A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment

January 6, 2026 updated by: Famy Life Sciences, a Viatris Company

A Randomized, Double-Masked, Vehicle-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment (MR-139), in Subjects With Blepharitis

The objective of this study is to determine the efficacy and safety of Pimecrolimus 0.3% (MR-139) Ophthalmic Ointment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is designed to evaluate Pimecrolimus 0.3% Ophthalmic Ointment in subjects with blepharitis to complete resolution (score = 0 on grading scale of 0-4) for eyelid debris after BID use at Week 6 in the Study Eye.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
477

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Pheonix, Arizona, United States, 85032
        • Clinical Investigative Site
    • California
      • Garden Grove, California, United States, 92843
        • Clinical Investigator Site
      • Glendale, California, United States, 91204
        • Clinical Investigator Site
      • Inglewood, California, United States, 90301
        • Clinical Investigator Site
      • Newport Beach, California, United States, 92663
        • Clinical Investigator Site
      • Petaluma, California, United States, 94954
        • Clinical Investigator Site
      • Rancho Cordova, California, United States, 95670
        • Clinical Investigator Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Clinical Investigator Site
    • Florida
      • Crystal River, Florida, United States, 34429
        • Clinical Investigator Site
      • Largo, Florida, United States, 33773
        • Clinical Investigator Site
      • Tampa, Florida, United States, 33603
        • Clinical Investigator Site
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Clinical Investigator Site
      • Morrow, Georgia, United States, 30260
        • Clinical Investigator Site
    • Kansas
      • Pittsburg, Kansas, United States, 66762
        • Clinical Investigator Site
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Clinical Investigator Site
    • Maryland
      • Havre de Grace, Maryland, United States, 21078
        • Clinical Investigator Site
    • Minnesota
      • Medina, Minnesota, United States, 55340
        • Clinical Investigator Site
    • Missouri
      • Kansas City, Missouri, United States, 64154
        • Clinical Investigator Site
      • St Louis, Missouri, United States, 63131
        • Investigative Site
      • Washington, Missouri, United States, 63090
        • Clinical Investigator Site
    • North Carolina
      • Garner, North Carolina, United States, 27529
        • Clinical Investigator Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Clinical Investigator Site
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Clinical Investigator Site
    • Tennessee
      • Smyrna, Tennessee, United States, 37167
        • Clinical Investigator Site
    • Texas
      • Austin, Texas, United States, 78731
        • Clinical Investigator Site
      • Lakeway, Texas, United States, 78738
        • Clinical Investigator Site
      • San Antonio, Texas, United States, 78229
        • Clinical Investigator Site
    • Utah
      • Clinton, Utah, United States, 84015
        • Clinical Investigator Site
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Clinical Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subjects aged ≥ 2 years of age or older at Visit 1, with a diagnosis of blepharitis confirmed by the investigator.
  2. Subjects under 18 must able to be examined at the slit lamp (handheld) without systemic anesthesia.
  3. A self-reported history of at least 1 previous episode of blepharitis.
  4. Adult subjects have provided verbal and written informed consent. For subjects under 16 years of age, a parent or legal guardian of each subject must provide written informed consent and sign the HIPAA form (or equivalent, if applicable), approved by the appropriate Institutional Review Board (IRB)/Ethical Committee (EC). Whenever practical and appropriate per local requirements, a child's assent should also be sought before inclusion into the study.
  5. Subjects who have not responded adequately to lid hygiene in the past (self-reported).
  6. Have a Corrected Distance Visual Acuity (CDVA) greater than or equal to 0.7 logMar in each eye, assessed with the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Subjects may be refracted if needed.
  7. Subjects must be able to comply with the requirements of the protocol including the ability to self-administer or receive topical treatment twice a day to their eyelid margins.
  8. Be literate and able to complete questionnaires independently, or in the case of pediatric patients, can comprehend the questionnaires with the help of a parent/guardian or interviewer.
  9. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at Visit 1 and must be willing to use an adequate method of contraception throughout the study and 30 days from the last application of the study treatment.

Exclusion Criteria:

  1. Subjects who have received a COVID vaccination or recovered from COVID-19 symptoms less than 1 week prior to baseline visit.
  2. Subjects with a history of, or active herpetic or neurotrophic keratitis.
  3. Subjects who, in the opinion of the investigator, have abnormal eyelid anatomy (other than due to blepharitis) that might adversely affect clinical signs and symptoms, including but not limited to lagophthalmos, malposition of the eyelid or tumor(s) of the eyelid or eyelid margin.
  4. Subjects who have received other treatments for blepharitis within 30 days of Visit 1.
  5. Subjects with known hypersensitivity to study medications, or to any diagnostic agents to be used in the study.
  6. Subjects who are currently enrolled in an investigational drug or device study or have used an investigational drug or device within the 30 days prior to the baseline visit and during the treatment period.
  7. Subjects who, in the opinion of the investigator, would be unable to adhere to the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Pimecrolimus 0.3% Ophthalmic Ointment
Study Drug
Drug: Pimecrolimus 0.3% Ophthalmic Ointment
Pimecrolimus 0.3% Ophthalmic Ointment will be applied twice a day to both eyelid margins.
Placebo Comparator: Placebo Ophthalmic Ointment
Placebo
Drug: Placebo Ophthalmic Ointment
Placebo will be applied twice a day to both eyelid margins.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of Study Drug
Time Frame: 6 weeks
Complete Resolution (score =0 on grading scale 0-4) of eyelid debris. A higher score indicates a worse outcome.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ocular Discomfort Score
Time Frame: 6 weeks
Proportion with at least 50% reduction from baseline in ODS at Week 6. Ocular discomfort is assessed by visual analog scale on a scale from 0-100 where 0 indicates no discomfort and 100 indicates maximum. A higher score indicates a worse outcome.
6 weeks
Collarettes
Time Frame: 6 weeks
Proportion of complete resolution for collarettes (score =0 on grading scale 0-4) at Week 6. A higher score indicates a worse outcome.
6 weeks
Eyelid Redness
Time Frame: 6 weeks
Proportion of complete resolution (score =0 on grading scale 0-4) for eyelid redness (erythema) at Week 6. A higher score indicates a worse outcome.
6 weeks
Ocular Discomfort Score
Time Frame: 6 weeks
The mean change from baseline in ODS at Week 6. Ocular discomfort is assessed by visual analog scale on a scale from 0-100 where 0 indicates no discomfort and 100 indicates maximum. A higher score indicates a worse outcome.
6 weeks
Blepharitis Symptom Measurement
Time Frame: 6 weeks
Proportion of complete resolution (score =0 on grading scale of 0-3) for the Eye Irritation Symptom on the BLISS at Week 6. A higher score indicates a worse outcome.
6 weeks
Eyelid Meibum Character
Time Frame: 6 weeks
Proportion of complete resolution (score = 0 on grading scale 0-24 for upper lid; 0-15 for lower lid) for eyelid meibum character at Week 6. A higher score indicates a worse outcome.
6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eyelid Swelling
Time Frame: 6 weeks
Complete resolution (score =0 on grading scale 0-4) and change from baseline eyelid swelling. A higher score indicates a worse outcome.
6 weeks
Eyelid Redness
Time Frame: 6 weeks
Complete resolution (score =0 on grading scale 0-4) and change from baseline for eyelid redness. A higher score indicates a worse outcome.
6 weeks
Eyelid Redness
Time Frame: 12 weeks
Complete resolution (score =0 on grading scale 0-4) and change from baseline for eyelid redness. A higher score indicates a worse outcome.
12 weeks
Eyelid Meibomian Gland Plugging
Time Frame: 12 weeks
Complete resolution (score =0 on grading scale 0-4) and change from baseline eyelid meibomian gland plugging. A higher score indicates a worse outcome.
12 weeks
Eyelid Meibum Character
Time Frame: 12 weeks
Complete resolution and change from baseline for eyelid meibum character
12 weeks
Eyelid Swelling
Time Frame: 12 weeks
Completion resolution (score =0 on grading scale 0-4) and change from baseline for eyelid swelling. A higher score indicates a worse outcome.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Famy Life Sciences, a Viatris Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Marian Macsai, MD, Viatris Eye Care Division

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCLS-OMZ-3001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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